Announcement • Jan 05

Cingulate Inc. Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day Treatment for ADHD

Cingulate Inc. announced the initiation of the first Phase 3 clinical trial of its lead candidate CTx-1301, a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate, a compound approved by the U.S. Food and Drug Administration (FDA) for the treatment of attention deficit/hyperactivity disorder (ADHD). Along with the commencement of its Phase 3 trial, the Company announced that Shane J Schaffer, Chairman and Chief Executive Officer (CEO), will host investor and business development meetings January 9-11, 2023, in San Francisco, CA. The meetings will take place at the same time as the annual J.P. Morgan Healthcare Conference. The Phase 3 clinical trial is an adult dose-optimization study to assess the onset and duration of efficacy along with the safety of CTx-1301 in adults with ADHD compared to placebo. The trial is expected to take three months to complete and initial results are expected in the first half of 2023. Of the multitude of medications available for the more than 17 million child, adolescent, and adult patients in the U.S. living with ADHD, no currently available medications offer a single oral dose that provides patients entire active-day efficacy. This Phase 3 trial is being conducted in an Adult Laboratory Setting (ALS) which has been used extensively to evaluate the efficacy of ADHD medications. CTx-1301 is the first medication aiming to achieve fast onset of action (in 30 minutes or less) and efficacy that lasts up to 16 hours. Cingulate’s proprietary PTR platform unlocks the opportunity to provide once-daily, multi-dose delivery tablets in large addressable markets, including the $18 billionU.S. ADHD market. Cingulate’s approach is designed to provide entire active-day efficacy and a fast onset of action in a single tablet with the potential for improved tolerability. Additionally, Cingulate’s approach aims to reduce patient cost by offering eight dose strengths that medical professionals can use to optimize a patient’s medication with a single co-pay. The PTR platform has the opportunity to be used for delivery of medications in other large markets, including anxiety (CTx-2103 in development), insomnia, depression, bipolar disorder, Parkinson’s disease, xerostomia (dry mouth), migraine, and hypothyroidism. Cingulate is available to partner with existing therapeutic providers in these and other categories to improve delivery and provide ideal, once-daily dosing solutions for patients. ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., approximately 6.4 million children and adolescents (11%) aged under the age of 18 have been diagnosed with ADHD. Among this group, approximately 80% receive treatment, with 65% demonstrating clinical ADHD symptoms that persist into adulthood. Adult ADHD prevalence is estimated at approximately 11 million patients (4.4%), almost double the size of the child and adolescent segment combined, however, only an estimated 20% receive treatment. Although there is no single medical, physical, or genetic test for ADHD, qualified mental health care professionals and physicians can provide a diagnostic evaluation after gathering information from multiple sources, including: ADHD symptom checklists, standardized behavior rating scales, detailed histories of past and current functioning, and information obtained from family members or significant others who know the person well. Some practitioners will also conduct tests of cognitive ability and academic achievement to rule out a possible learning disability. The first Phase 3 study (CTx-1301-022, NCT05631626 [3]) for CTx-1301 is a single-center, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy and safety ALS study with CTx-1301 in approximately 25 adults aged 18 to 55 years with ADHD. The study will be comprised of a screening period, a dose-optimization phase, a double-blind randomized phase, and a safety follow-up phase. Subjects will undergo a screening visit prior to entering a five-week dose-optimization phase. During the dose-optimization phase, subjects will have weekly visits and will be titrated to doses ranging between 25 mg and 50 mg of CTx-1301. Cingulate is utilizing an ALS, which enables the Company to facilitate repeated assessments over the course of a day to evaluate the onset and duration of efficacy provided by CTx-1301. Eligible subjects will be randomized to their optimal dose or placebo in a 1:1 ratio after completing a practice visit with four Permanent Product Measure of Performance (PERMP) assessments. Subjects will take their assigned/randomized dose over the following seven-day period. On the seventh day, subjects will complete a full ALS visit. The duration of the full ALS visit will be approximately 17 hours. Subjects will have an in-clinic safety follow-up visit within seven days after the full ALS visit. The primary objective of CTx-1301-022 is to evaluate the efficacy of CTx-1301 compared to placebo in treating adults with ADHD in an ALS study. Secondary objectives include determination of the onset and duration of clinical effect of CTx-1301 in treating ADHD in adults in an ALS study and to determine safety and tolerability of CTx-1301 compared to placebo. The study will also evaluate the quality and satisfaction of prior medication to CTx-1301. The Phase 3 clinical trial program for CTx-1301 will be conducted in the U.S. and is instrumental for the filing of the New Drug Application (NDA) to the FDA, expected in the first half of 2024. Cingulate’s lead candidate, CTx-1301, utilizes the Company’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylph enidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold-standard of ADHD treatment due to their efficacy and safety, the long-standing challenge remains, providing patients entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off. The company has initiated the first of two Phase 3 clinical studies of CTx-1301 to support its NDA submission. The pivotal, Phase 3 fixed-dose trial in children and adolescents is scheduled to begin in mid-2023.

Pharmaceuticals Industry Growth	5.95%
Revenue growth rate	n/a
Return on equity	-122.71%
Net Margin	n/a
Last Earnings Update	30 Jun 2026

Date	Earnings	G+A Expenses
30 Jun 26	-29	16
31 Mar 26	-28	14
31 Dec 25	-22	10
30 Sep 25	-22	8
30 Jun 25	-19	7
31 Mar 25	-17	7
31 Dec 24	-17	6
30 Sep 24	-17	6
30 Jun 24	-19	6
31 Mar 24	-23	7
31 Dec 23	-24	7
30 Sep 23	-21	8
30 Jun 23	-19	8
31 Mar 23	-17	8
31 Dec 22	-18	9
30 Sep 22	-16	7
30 Jun 22	-27	7
31 Mar 22	-24	6
31 Dec 21	-21	4
30 Sep 21	-19	3
30 Jun 21	-5	2
31 Mar 21	-6	2
31 Dec 20	-7	2

Data	Last Updated (UTC time)
Company Analysis	2026/09/13 02:23
End of Day Share Price	2026/09/11 00:00
Earnings	2026/06/30
Annual Earnings	2025/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
Edward Woo	Ascendiant Capital Markets LLC
Raghuram Selvaraju	H.C. Wainwright & Co.
Nazibur Rahman	Maxim Group

Cingulate Past Earnings Performance

Past criteria checks 0/6

Key information

Recent past performance updates

Recent updates

Price target decreased by 7.8% to US$21.20

Cingulate Publishes Peer-Reviewed Data Demonstrating CTx-1301’s Differentiated Pharmacokinetic Profile

Cingulate Announces Publication Of Phase 3 Clinical Trial Results For CTx-1301 For ADHD

Cingulate Inc. Announces Termination of Nilay Patel as Chief Legal Officer, Effective August 3, 2026

Cingulate Inc. Announces Board and Committee Changes, Effective July 9, 2026

Cingulate Added to Russell 3000E Index Boosting Institutional Investor Visibility

Price target decreased by 7.7% to US$23.00

Cingulate Receives Complete Response Letter for Ctx-1301

Price target decreased by 9.8% to US$25.90

Cingulate Inc., Annual General Meeting, Jul 09, 2026

New major risk - Financial position

Price target increased by 24% to US$33.88

Price target increased by 7.1% to US$29.30

Cingulate Inc. has filed a Follow-on Equity Offering in the amount of $100 million.

No longer forecast to breakeven

Cingulate Inc. has completed a Follow-on Equity Offering in the amount of $23.5 million.

High number of new and inexperienced directors

Cingulate Inc. announced that it has received $11.796254 million in funding

New minor risk - Share price stability

Cingulate Inc. announced that it expects to receive $12.011001 million in funding

Forecast to breakeven in 2028

New minor risk - Profitability

Cingulate Inc. Appoints Bryan Downey as Chief Commercial Officer

Cingulate Inc. announced that it has received $6.57 million in funding

Cingulate Presents Positive Phase 3 Results for CTx-1301 Demonstrating Statistically Significant Efficacy and Entire Active-Day Symptom Control

Cingulate's Lead ADHD Candidate CTx-1301 Selected for Podium Presentation At AACAP Annual Meeting

FDA Accepts Cingulate's New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and Sets a May 31, 2026 PDUFA Date

Cingulate Inc. announced delayed 10-Q filing

Cingulate Inc. Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301

Cingulate Inc. Receives $4.3 Million Waiver from Fda Ahead of Imminent Filing for Marketing Approval of Lead Adhd Asset Ctx-1301

Cingulate Inc. Appoints Nilay Patel as Chief Legal Officer

Cingulate Inc. Announces Efficacy Results from Phase 3 Pediatric Study of CTx-1301 (Dexmethylphenidate) for ADHD

Cingulate Inc. Receives Formal Pre-New Drug Application Meeting Minutes from the U.S. Food and Drug Administration

Cingulate Announces Positive Top-Line Results from High-Dose (50Mg) Fed/Fast Study of Lead Asset CTx-1301 for ADHD

Cingulate Inc., Annual General Meeting, Jun 10, 2025

Cingulate Inc. Completes Pre-NDA Meeting with FDA to Discuss New Drug Application for Lead ADHD Asset CTx-1301

Cingulate Inc. Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: on Track to File for FDA Approval Mid-2025

Cingulate Inc. Completes its Final FDA- Required Study for CTx-1301 for the Treatment of Attention Deficit Hyperactivity Disorder

The Nasdaq Hearings Panel Grants Cingulate's Request for an Exception to Demonstrate Compliance with the $1.00 Minimum Bid Price Requirement Set in Nasdaq Listing Rule 5550(a)(2) for Continued Listing Through August 23, 2024

Cingulate Receives Letter from Nasdaq Due to Non-Compliance with the Minimum Bid Price Requirement Under Nasdaq Listing Rule 5550(a)(2) for Continued Listing on The Nasdaq Capital Market

Cingulate Inc., Annual General Meeting, Jun 11, 2024

Cingulate Inc. Regains Compliance with the Board Composition Requirements of Nasdaq Set in Nasdaq Listing Rule 5605

Cingulate Appoints Jay Roberts, Bryan Lawrence, and Jeff Ervin to Its Board of Directors

Cingulate Inc. has completed a Follow-on Equity Offering in the amount of $7.5 million.

Cingulate Inc. has completed a Follow-on Equity Offering in the amount of $7.5 million.

Cingulate Inc. Announces Promotion of Jennifer Callahan as Chief Financial Officer

Cingulate Inc. has filed a Follow-on Equity Offering in the amount of $26 million.

Cingulate Receives Non-Compliance Notice from Nasdaq

Cingulate Inc. and Cingulate Therapeutics LLC Announce Resignation of Officer

Scott Applebaum Provides Cingulate Inc. with Notice of His Resignation from the Board of Directors

Cingulate Receives Guidance from FDA on Path Forward for Anxiety Asset CTX-2103 (Buspirone)

Cingulate Inc. has filed a Follow-on Equity Offering.

The Listing Qualifications Staff of The Nasdaq Stock Market LLC Determines to Delist Cingulate's Securities from Nasdaq Unless it Timely Requests Hearing Before the Nasdaq Hearings Panel

Cingulate Inc. to Host CNS Key Opinion Leader Panel in New York City Expert Analysis of Cingulate, it’s Phase 3 ADHD Adult Data, Anxiety, and PTR™ Drug Delivery Platform Innovations

Cingulate Weighs Reverse Stock Split to Avoid Delisting

Cingulate Inc. has completed a Follow-on Equity Offering in the amount of $4 million.

New major risk - Shareholder dilution

New major risk - Negative shareholders equity

Cingulate Inc. Receives A Written Notice from Nasdaq Regarding Minimum Bid Price Requirement

Cingulate Inc. Announces Positive Top-Line Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (Dexmethylphenidate) for Adhd

Cingulate Inc. Successfully Manufactures Clinical Supply Initiation of Pediatric Phase 3 Studies to Commence in July and August

New major risk - Market cap size

Cingulate Completes Phase 3 Adult Trial of Ctx-1301 (Dexmethylphenidate) for Adhd

Cingulate Receives Non-Compliance Notice from Nasdaq Regarding Non-Compliance with the Minimum Stockholders’ Equity Requirement

Cingulate Inc., Annual General Meeting, Jun 15, 2023

Forecast to breakeven in 2025

No longer forecast to breakeven

Cingulate Inc. Announces Resignation of Jeff Conroy from the Board of Directors

Cingulate Inc. Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day Treatment for ADHD

Independent Director recently bought US$75k worth of stock

Cingulate Inc. Completes Fed/Fast Study Assessing Food Effect with CTx-1301, Lead Candidate for Treatment of ADHD

Cingulate Inc. Provides Clinical Update

Cingulate Inc. Announces the Resignation of Jeff Hargroves from the Board of Directors

Cingulate Presents Data for its Triple-Release Buspirone Product Candidate: CTx-2103

Here's Why We're A Bit Worried About Cingulate's (NASDAQ:CING) Cash Burn Situation